BEUDAMED
    FDA Enforcement Class II Terminated

    PHALINX (TM) HAMMERTOE HANDLE, SIZE: LARGE, STYLE: ANGLED, REF 45304014, CONTENTS 1 EACH, RX ONLY

    Recall: Z-1627-2015 · Reported May 27, 2015

    Enforcement

    Recall Number
    Z-1627-2015
    Event ID
    71143
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Wright Medical Technology, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 27, 2015
    Initiation Date
    April 16, 2015
    Classification Date
    May 18, 2015
    Termination Date
    October 18, 2018
    Address
    1023 Cherry Rd, N/A, Memphis, TN, 38117-5423, United States

    Description

    PHALINX (TM) HAMMERTOE HANDLE, SIZE: LARGE, STYLE: ANGLED, REF 45304014, CONTENTS 1 EACH, RX ONLY

    Reason

    The term DORSAL was laser etched on the incorrect side on some of the angled handles.

    Code Info

    Lot 1344534

    Distribution

    Nationwide Distribution

    Quantity

    126 units